DiarrheaPhase 3NCT00650637
A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
A Phase 3 study testing Calcium Carbonate, nelfinavir and lamivudine in people with Diarrhea, run by Pfizer at 6 sites in United States.
Trial summary
The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea
- What is being tested?
- Calcium Carbonate, nelfinavir and lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2003to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Antiretroviral-naive patients with HIV-1 infection
- not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug
- No antidiarrheal medication within 7 days prior to entry
Who cannot join
- Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry
- Bloody stools within 7 days prior to study entry
- Any unstable or severe intercurrent medical condition, including active opportunistic infections
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Houston, Texas, 77098
Pfizer Investigational Site
Huntersville, North Carolina, 28078
Pfizer Investigational Site
New York, New York, 10011
About this study
Official title: A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea
The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.
- Conditions
- Diarrhea
- Being tested
- Calcium Carbonate, nelfinavir, lamivudine, loperamide, Calcium carbonate not administered
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CarbonateDrug
Calcium carbonate 500 mg oral tablet twice a day; given in combination with the following antiretroviral combination: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; All study drugs continued through to Week 12
nelfinavirDrug
Also called Viracept
1250 mg twice a day
lamivudineDrug
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
loperamideDrug
If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;
Calcium carbonate not administeredOther
Prophylaxis with calcium carbonate not administered in this group; The following antiretroviral combination was administered: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
nelfinavirDrug
Also called Viracept
nelfinavir 1250 mg twice a day
lamivudine + zidovudineDrug
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Calcium Carbonate; Drug: nelfinavir; Drug: lamivudine; Drug: loperamide |
| 2 | Experimental | Not described Receives: Other: Calcium carbonate not administered; Drug: nelfinavir; Drug: lamivudine + zidovudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experienced protocol-defined diarrhea in each treatment group during study
Measured: Week 12
Secondary outcomes (5)
Time to first occurrence of protocol-defined diarrhea
The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea
Measured: Weeks 2, 4, 6, 8, and 12
Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide
Measured: Weeks 2, 4, 6, 8, and 12
Safety evaluations including physical exam, weight and vital signs measurements
Measured: Screening, baseline, Weeks 2, 4, 6, 8, and 12
Safety assessment of laboratory parameters
Measured: Screening, baseline, Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startJan 2003
- Primary completionAug 2003
- Study completionAug 2003
Why it stopped: The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650637
- Sponsor's protocol ID
- A4301004
- Status last verified
- Jun 2011
- First submitted
- 31 Mar 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea
- ClinicalTrials.gov ID
- NCT00650637
- Acronym / sponsor ID
- A4301004
- Conditions
- Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Calcium Carbonate, Drug: nelfinavir, Drug: lamivudine, Drug: loperamide |
| 2 | Experimental | Other: Calcium carbonate not administered, Drug: nelfinavir, Drug: lamivudine + zidovudine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Antiretroviral-naive patients with HIV-1 infection
- not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug
- No antidiarrheal medication within 7 days prior to entry
Key exclusion criteria (3 listed)
- Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry
- Bloody stools within 7 days prior to study entry
- Any unstable or severe intercurrent medical condition, including active opportunistic infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium CarbonateCalcium carbonate 500 mg oral tablet twice a day; given in combination with the following antiretroviral combination: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; All study drugs continued through to Week 12 | Drug | 1 |
| nelfinavirAlso: Viracept1250 mg twice a day | Drug | 1 |
| lamivudinelamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); | Drug | 1 |
| loperamideIf diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; | Drug | 1 |
| Calcium carbonate not administeredProphylaxis with calcium carbonate not administered in this group; The following antiretroviral combination was administered: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); | Other | 2 |
| nelfinavirAlso: Viraceptnelfinavir 1250 mg twice a day | Drug | 2 |
| lamivudine + zidovudinelamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); | Drug | 2 |
Primary outcome
Number of patients who experienced protocol-defined diarrhea in each treatment group during study
Time frame: Week 12
5 secondary outcomes
Time to first occurrence of protocol-defined diarrhea
The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea
Time frame: Weeks 2, 4, 6, 8, and 12
Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide
Time frame: Weeks 2, 4, 6, 8, and 12
Safety evaluations including physical exam, weight and vital signs measurements
Time frame: Screening, baseline, Weeks 2, 4, 6, 8, and 12
Safety assessment of laboratory parameters
Time frame: Screening, baseline, Weeks 4, 8, and 12
Results and safety
The study was stopped early (reason given: The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium Carbonate, nelfinavir and lamivudine in people with Diarrhea, run by Pfizer at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experienced protocol-defined diarrhea in each treatment group during study (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.